MHRA Grants Marketing Authorisation for Opzelura® (ruxolitinib) Cream for the Treatment of Non-Segmental Vitiligo with Facial Involvement in Adults and Adolescents

Rhea-AI Summary

Opzelura® (ruxolitinib) cream has been granted marketing authorization by the MHRA for the treatment of non-segmental vitiligo with facial involvement in the UK. The approval is based on Phase 3 data showing improved repigmentation with longer treatment duration. Vitiligo affects around 1 in 100 people in the UK.

Positive

• Opzelura® is the first approved treatment in the UK for non-segmental vitiligo, providing support for repigmentation. The approval is based on Phase 3 data showing significant improvements in facial and total body repigmentation. At Week 24, 29.8% and 30.9% of patients treated with ruxolitinib cream achieved ≥75% improvement in the facial Vitiligo Area Scoring Index (F-VASI75) compared to 7.4% and 11.4% of patients treated with vehicle. At Week 52, approximately one in two patients achieved F-VASI75 and one in three achieved ≥90% improvement in F-VASI.

Negative

• None.

• Opzelura^® is the first approved treatment in the United Kingdom (UK) to address repigmentation in non-segmental vitiligo
• Phase 3 data supporting the approval show treatment with ruxolitinib cream resulted in improved facial and total body repigmentation, sustained and continued improvements with longer duration of treatment
• Vitiligo affects around 1 in 100 people in the UK

LEATHERHEAD, England--(BUSINESS WIRE)-- Incyte Biosciences UK today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for Opzelura^® (ruxolitinib) cream 15mg/g for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. Opzelura is the first and only approved treatment in the United Kingdom (UK) to offer eligible patients with non-segmental vitiligo support for repigmentation. The MHRA decision follows the European Commission approval¹ earlier in April.

“Today’s MHRA approval is welcome news for dermatologists and people with vitiligo seeking treatment who until now have had limited options. The data supporting this approval demonstrate the potential for ruxolitinib cream to make a difference in the lives of people living with this condition,” said Dr. Viktoria Eleftheriadou, Consultant Dermatologist & Lead for Vitiligo Clinic and Research, Walsall Healthcare NHS Trust and The Royal Wolverhampton NHS Trust.

Vitiligo is a chronic autoimmune disease in which areas of skin depigment or lose their colour due the progressive destruction of pigment-producing cells known as melanocytes². Around 1 in 100 people in the UK develop vitiligo^3,4 with approximately 8 in 10 patients suffering from non-segmental vitiligo, where both sides of the body are affected by symmetrical white patches⁵. Vitiligo can occur at any age, although many patients with vitiligo will experience initial onset before the age of 30⁴, and have a significant impact on people living with the condition⁶.

“While more and more people are proud of their vitiligo, there are still so many people who don’t feel comfortable in their skin,” said Emma Rush, Founder and Chief Executive Officer, Vitiligo Support UK. “This new treatment option provides a choice for those who wish to treat their condition.”

The MHRA decision is based on data from two pivotal Phase 3 clinical trials (TRuE-V1 [NCT04052425] and TRuE-V2 [NCT04057573]), evaluating the efficacy and safety of ruxolitinib cream versus vehicle (non-medicated cream) in more than 600 people with non-segmental vitiligo, age 12 and older⁷. Results from the TRuE-V program showed that treatment with ruxolitinib cream resulted in significant improvements in facial and total body repigmentation versus vehicle as shown by the number of patients reaching the facial and total body Vitiligo Area Scoring Index (F-VASI-T-VASI) endpoints at Week 24 compared to vehicle and in an open-label extension at Week 52⁷.

Results at Week 24, which were consistent across both studies, showed that 29.8% and 30.9% of patients treated with ruxolitinib cream achieved ≥75% improvement from baseline in the facial Vitiligo Area Scoring Index (F-VASI75), the primary endpoint, compared to 7.4% and 11.4% of patients treated with vehicle in TRuE-V1 and TRuE-V2, respectively⁷. At Week 52, approximately one in two of ruxolitinib cream-treated patients achieved F-VASI75⁷. Additionally, at Week 52, approximately one in three of ruxolitinib cream-treated patients achieved ≥90% improvement from baseline in F-VASI (F-VASI90)⁷.

There were no serious treatment-related adverse events related to ruxolitinib cream and the most common adverse reaction was application site acne⁷.

For additional information, please consult the full Summary of Product Characteristics.

“We are delighted to announce the MHRA approval of Opzelura for people living with non-segmental vitiligo with facial involvement,” said Peter Williams, General Manager, Incyte United Kingdom and Ireland. “We are now working in partnership with the NHS to ensure that eligible patients seeking to treat their vitiligo are able to access this innovative medicine.”

”A new treatment specifically approved for vitiligo in the UK is a significant milestone and furthers our goal at The Vitiligo Society to support, inspire and educate people about vitiligo,” said John Dunster, Chairperson, The Vitiligo Society.

About Opzelura^® (ruxolitinib) Cream 15mg/g

Ruxolitinib cream, a novel formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, is the first and only topical JAK inhibitor approved for use in the UK indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age⁷.

In eligible patients, ruxolitinib cream is approved for topical use twice daily to the depigmented skin areas up to a maximum of 10% body surface area⁷. Satisfactory repigmentation may require treatment with ruxolitinib cream for more than 24 weeks⁷.

Ruxolitinib cream is approved in the European Union for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

In the United States, ruxolitinib cream is approved for the topical treatment of non-segmental vitiligo in patients 12 years of age and older. Ruxolitinib cream is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of ruxolitinib cream in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended.

Incyte has worldwide rights for the development and commercialisation of ruxolitinib cream, marketed in the United States and Europe as Opzelura.

Opzelura and the Opzelura logo are registered trademarks of Incyte.

About Incyte Dermatology

Incyte’s science-first approach and expertise in immunology has formed the foundation of the company. Today, we are building on this legacy as we discover and develop innovative dermatology treatments to bring solutions to patients in need.

Our research and development efforts in dermatology are initially focused on leveraging our knowledge of the JAK-STAT pathway. We are exploring the potential of JAK inhibition for a number of immune-mediated dermatologic conditions with a high unmet medical need, including atopic dermatitis, vitiligo, lichen planus, lichen sclerosus and prurigo nodularis.

To learn more, visit the Dermatology section of Incyte.com.

About Incyte

Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialisation of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

Forward-Looking Statements

Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding whether and when Opzelura will provide a successful treatment option for patients with vitiligo, contain predictions, estimates and other forward-looking statements.

These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; determinations made by the MHRA, the European Commission and other regulatory authorities; the Company’s dependence on its relationships with its collaboration partners; the efficacy or safety of the Company’s products; the acceptance of the Company’s products in the marketplace; market competition; sales, marketing, manufacturing, and distribution requirements; and other risks detailed from time to time in the Company’s reports filed with the U.S. Securities and Exchange Commission, including its annual report for the year ending December 31, 2022 and subsequent quarterly reports. The Company disclaims any intent or obligation to update these forward-looking statements.

¹ Incyte. (2023, April 20). Incyte Announces European Commission Approval Of Opzelura® (Ruxolitinib) Cream For The Treatment Of Non-Segmental Vitiligo With Facial Involvement In Adults And Adolescents [Press release] https://investor.incyte.com/news-releases/news-release-details/incyte-announces-european-commission-approval-opzelurar
² Frisoli M, et al. Vitiligo: mechanisms of pathogenesis and treatment. Annual. Review of Immunology. 2020; 38(1):621-648.
³ Bibeau K, et al. Vitiligo prevalence and quality of life among adults in Europe, Japan and the USA. Journal of the European Academy of Dermatology and Venerology. 2022; V36(10), P 1831-1844.
⁴ Mohr N, et al. Epidemiology of Vitiligo - A Dual Population-Based Approach. Clinical Epidemiology. 2021 May 26; 13:373-382.
⁵ Gandhi K, et al. Prevalence of Vitiligo Among Adults in the United States. JAMA Dermatol. 2022 Jan 1;158(1):43-50.
⁶ Bibeau K, et al. Maui Derm for Dermatologists 2022. ePoster on Diagnosis and Management of Vitiligo From the Perspectives of Patients and Healthcare Professionals: Findings From the Global VALIANT Study.
⁷ Opzelura® (ruxolitinib) cream 15mg/g. UK Summary of Product Characteristics. Incyte; July 2023.

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Media

Ela Zawislak

+41 21 343 3113

ezawislak@incyte.com



Lottie Williams, Curious Health

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Investors

Greg Shertzer

+1 302 274 4779

gshertzer@incyte.com

Source: Incyte

FAQ

What is Opzelura® and what is it used for?

Opzelura® is a cream containing ruxolitinib and it is used for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

How effective is ruxolitinib cream for repigmentation?

Phase 3 data showed that treatment with ruxolitinib cream resulted in significant improvements in facial and total body repigmentation. At Week 24, almost 30% of patients achieved ≥75% improvement in the facial Vitiligo Area Scoring Index (F-VASI75).

What are the common side effects of ruxolitinib cream?

The most common adverse reaction to ruxolitinib cream is application site acne. There were no serious treatment-related adverse events reported.